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Protocol for the Use of
Recombinant DNA Molecules and Infectious Agents
1. Project Title:
2. Principal Investigator:
Mail Address:
Office Phone: (
Lab Phone: (
)
)
Home Phone: (
-
)
-
3. Alternative Responsible Individual:
Mail Address:
Office Phone: (
Lab Phone: (
Home Phone: (
4. This application is:
)
)
-
)
New
3. Anticipated study dates: From
Renewal
Modification
To
4. Please provide an abstract and specific aims of proposal.
5. At what site will the research be conducted?
6. Will this research involve human gene transfer experiments (i.e., the deliberate
transfer of recombinant DNA, or DNA or RNA derived from recombinant DNA into
human subjects)?
Yes
No
Protocol for the Use of Recombinant DNA
Molecules and Infectious Agents
Will this research involve:
7. the cloning of toxin molecules with LD50 of less than 100 nanograms per kilogram of
body weight in vertebrates?
Yes
No
8. the deliberate transfer of a drug resistance trait to microorganisms that are not
known to acquire the trait naturally?
Yes
No
9. If you answered yes to question 8, is the drug also used in the treatment of disease
caused by this microorganism in humans or animals?
Yes
10.
No
the use of human blood products, body fluids or tissues?
Yes
11.
No
either infectious DNA/RNA viruses OR defective viruses (<2/3 of the viral genome) in
the presence of helper virus in tissue culture systems?
Yes
12.
the creation of transgenic animals or plants?
Yes
13.
No
No
List all microbial organisms that will be used either directly or as a source of DNA for
this research. Include the indicated information (see Appendix of NIH Guidelines,
Safety Materials section of CHORI library, for Risk Group Classification).
Organism
Risk Group
Live
Yes/No
Source of DNA
Yes/No
Human Pathogen
Yes/No
Protocol for the Use of Recombinant DNA
Molecules and Infectious Agents
14.
Describe any use of infectious agents and/or recombinant DNA activities that will be
performed in pursuing this project. Address the following questions in your
response, or check box below.
Neither infections agents or recombinant DNA molecules are used in this
project.
a. Will greater than 10 liters of culture be used at one time?
b. If the organism is a human pathogen, is a vaccine available?
c. If the answer to 14b is yes, has this vaccine been offered to all laboratory
employees, and does the P.I. have written documentation of either vaccination or
refusal to receive vaccination on all employees?
d. Will this proposal involve animal inoculation?
e. Will there be a high likelihood of aerosolization in the handling of this organism?
f. Indicate:
i.
the source(s) of DNA (from which animal/organism is sequence derived?)
ii.
the nature of inserted DNA sequences
iii.
the host(s) and vector(s) to be used
iv.
if any attempt will be made to obtain expression of a foreign gene, and if
so, indicate the protein that will be produced
v.
the containment conditions that will be implemented, as specified in the
NIH Guidelines.
g. Provide a brief plan to be used in the event of emergency spills or contamination
or personnel and/or environment.
15.
Describe any real or potential risk to humans or the environment posed by this
research, or check box below. What steps are you taking to prevent such risks?
No risks to humans or the environment are posed by this research.
Signature of Principal Investigator
Date